US Sets Up Rapid Response Team Against Avian Flu
Posted on: Tuesday, 25 October 2005, 09:01 CDT
US sets up rapid response team against avian flu
LOS ANGELES, Oct. 24 (Xinhua)-- US Food and Drug Administration (FDA) on Monday set up a rapid response team to ensure the distribution of antiviral drugs if a flu pandemic is aroused by avian influenza.
Currently, the team will help ensure an adequate supply of treatments, such as Tamiflu and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the US, the FDA said in a statement.
"Using the rapid response team approach, we believe we could review a complete drug application in six to eight weeks," said Andrew von Eschenbach, acting FDA commissioner.
"Americans can be certain that FDA has the best scientific minds working together to ensure we have enough Tamiflu and other medications and to quickly get it to doctors and patients, if ever necessary," he said.
The drug regulator also urged pharmaceutical firms to accelerate the production of antiviral drugs, especially the proven medicine Tamiflu (oseltamivir phosphate).
If the Swiss drug maker Roche AG, which holds the patent of Tamiflu, allows other companies to begin producing the drug, the FDA will approve those factories' versions.
"It is anticipated that Tamiflu production can be in full gear within 12 months, with substantial product available, should it be needed," the statement said.
"The team will support the design and conduct of clinical studies to test new potential treatments for avian influenza. In the event of a pandemic, such new medications could be made available under Emergency Use Authorization," it added.
The team will also help increase vaccine manufacturing capacity and production of currently licensed vaccines using avian flu strains, facilitating and evaluating studies that use new technologies.
While the flu pandemic is emerging as a public health threat, the sale of counterfeit or fraudulent therapies will increase, the FDA warned.
"There are initiatives in place to deter counterfeiters and parties who sell fraudulent or phony products to treat or prevent avian flu," it said.
The agency said it will monitor Internet sites to identify and stop fraudulent activities, track the counterfeit drug sellers, and urge drug makers to protect their products better. It also advises people to be careful when they buy antiviral drugs via Internet.
Source: Xinhua News Agency - CEIS
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